ADI-001 / Adicet Bio - LARVOL DELTA

Adicet Bio Reports First Quarter 2025 Financial Results and Provides Business Updates (Businesswire) - "In April 2025, Adicet expanded enrollment in its Phase 1 trial to include patients with SLE, in addition to ongoing enrollment in LN. The Company expects to initiate enrollment for patients with systemic sclerosis (SSc), idiopathic inflammatory myopathy (IIM), stiff person syndrome (SPS) and anti-neutrophil cytoplasmic autoantibody associated vasculitis (AAV) in the Phase 1 trial in 3Q/2025. Preliminary clinical data from the trial is expected in 2H/2025, subject to study site initiation and patient enrollment."

P1 data • Trial status • Lupus Nephritis • Systemic Lupus Erythematosus • Systemic Sclerosis • Vasculitis

Adicet Bio Reports Fourth Quarter and Full Year 2024 Financial Results and Highlights Recent Company Progress (Businesswire) - "Phase 1 clinical trial of ADI-001 in autoimmune diseases ongoing; on track to report preliminary clinical data from lupus nephritis (LN) patient cohort in 1H25. Additional LN clinical data and preliminary clinical data from other autoimmune patient cohorts anticipated in 2H25. Initiation of ADI-001 Phase 1 clinical trial patient enrollment in systemic lupus erythematosus (SLE), systemic sclerosis (SSc), idiopathic inflammatory myopathy (IIM) and stiff person syndrome (SPS) expected in 2Q25; anti-neutrophil cytoplasmic autoantibody (ANCA) associated vasculitis (AAV) patient enrollment expected to be initiated in 2H25."

Enrollment status • P1 data • ANCA Vasculitis • Lupus Nephritis • Systemic Lupus Erythematosus • Systemic Sclerosis • Vasculitis

Adicet Bio Receives FDA Fast Track Designation for ADI-001 for the Treatment of Systemic Sclerosis (SSc) (Businesswire) - "Adicet Bio, Inc...today announced the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to ADI-001 for the potential treatment of adult patients with systemic sclerosis (SSc)."

Fast track • Systemic Sclerosis

Adicet Bio Receives FDA Fast Track Designation for ADI-001 for the Treatment of Refractory Systemic Lupus Erythematosus (SLE) with Extrarenal Involvement (Businesswire) - "Adicet Bio, Inc...today announced the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to ADI-001 for the potential treatment of adult patients with refractory systemic lupus erythematosus (SLE) with extrarenal involvement."

Fast track • Systemic Lupus Erythematosus

A Phase 1 Study of ADI-001 in Autoimmune Disease (clinicaltrials.gov) - P1 | N=180 | Recruiting | Sponsor: Adicet Therapeutics | N=40 ➔ 180

Enrollment change • ANCA Vasculitis • CNS Disorders • Glomerulonephritis • Immunology • Inflammatory Arthritis • Lupus • Lupus Nephritis • Myositis • Nephrology • Scleroderma • Systemic Lupus Erythematosus • Systemic Sclerosis • Vasculitis

Adicet Bio Provides Corporate Update and Highlights Expected 2025 Milestones (Businesswire) - "In November 2024, Adicet announced the dosing of the first LN patient in the Phase 1 trial of ADI-001 in autoimmune diseases. The Company expects to initiate enrollment for patients with SLE, SSc, IIM, and SPS in the first quarter of 2025, and for patients with AAV in the second half of 2025. Preliminary clinical data from the Phase 1 trial of ADI-001’s LN patient cohort are anticipated in the first half of 2025. Preliminary data from the Phase 1 trial’s other patient cohorts are expected in the second half of 2025."

P1 data • Trial status • ANCA Vasculitis • Lupus Nephritis • Systemic Lupus Erythematosus • Systemic Sclerosis

ADI-001: An Allogeneic CD20-targeted γδ CAR T Cell Therapy with Potential for Improved Tissue Homing in Autoimmune Indications (ACR Convergence 2024) - P1 | "ADI-001 is designed with a 2nd generation CAR incorporating a novel fully human anti-CD20 scFv, having a distinct binding epitope than that of rituxumab, and with 4-1BB and CD3ζ signaling domains. ADI-001 effectively accessed and targeted B cells in tissues/organs in preclinical and clinical settings, while also targeting primary B cells derived from patients with a spectrum of autoimmune disorders where dysfunctional B cells are implicated in disease pathogenesis. As ADI-001 demonstrated a tolerable inflammatory cytokine signature and favorable clinical safety profile, the combined features of ADI-001 represent a compelling alternative to autologous CD19-targeted CAR T cell therapies, with potential for improved efficacy against tissue-resident pathogenic B cells in autoimmune indications."

CAR T-Cell Therapy • Graft versus Host Disease • Immunology • Inflammatory Arthritis • Oncology • IL17A • IL6

Adicet Bio Presents Clinical Biomarker Data for Off-the-Shelf CAR T Cell Therapy in an Oral Session at the American College of Rheumatology (ACR) Convergence 2024 (Businesswire) - P1 | N=78 | GLEAN-1 (NCT04735471) | Sponsor: Adicet Therapeutics | "Adicet Bio...today announced that clinical biomarker data from the ADI-001 Phase 1 GLEAN trial which demonstrates robust tissue homing, significant CAR T cell activation, and complete CD19+ B cell depletion in secondary lymphoid tissue will be featured in an oral session at ACR Convergence 2024 in Washington, D.C., November 14-19....ADI-001 demonstrated significant levels of CAR T cell activation and tissue exposure in lymph node biopsies in the GLEAN trial, representing a range of 27-64% of total cellular material detected by ddPCR in evaluable biopsies at the 1E9 dose, and exceeding levels previously reported for patients who received autologous alpha-beta CAR T therapies. CAR T cells detected in tissues also demonstrated a robust activation profile, based on in situ levels of granzyme B."

Biomarker • P1 data • Immunology • Oncology

ADI-001 Clinical Biomarker Data Demonstrate Robust Tissue Trafficking and Complete B Cell Depletion in Secondary Lymphoid Tissue (Businesswire) - P1 | N=78 | GLEAN-1 (NCT04735471) | Sponsor: Adicet Therapeutics | "ADI-001 demonstrated significant levels of CAR T cell activation and tissue exposure in lymph node biopsies in the GLEAN trial, with a mean exposure of 236,701 CAR T cells per million across all dose levels, representing a range of 27-64% of total cellular material detected by ddPCR in evaluable biopsies at the 1E9 dose, and exceeding levels previously reported for patients who received autologous alpha-beta CAR T therapies...Adicet is advancing the ADI-001 clinical program in lupus nephritis, systemic lupus erythematosus, systemic sclerosis and anti-neutrophil cytoplasmic autoantibody associated vasculitis (AAV) and expects to report initial clinical data in the first half of 2025."

Biomarker • P1 data • ANCA Vasculitis • Hematological Malignancies • Immunology • Lupus Nephritis • Oncology • Systemic Lupus Erythematosus • Systemic Sclerosis

Adicet Bio Announces First Lupus Nephritis Patient Dosed in Phase 1 Clinical Trial of ADI-001 in Autoimmune Diseases (Businesswire) - "Adicet Bio...today announced that the first LN patient has been dosed in the Phase 1 clinical trial evaluating ADI-001 in autoimmune diseases....'Dosing the first lupus nephritis patient in our Phase 1 trial of ADI-001 marks an important step forward in our mission of improving the lives of patients affected by autoimmune diseases, particularly lupus nephritis,'..."

Trial status • Lupus Nephritis

Adicet Reports Third Quarter 2024 Financial Results and Provides Business Updates (Businesswire) - "Activated clinical sites in ADI-001 Phase 1 trial in autoimmune diseases: The Company opened enrollment for patients with LN in 4Q24 and expects to initiate enrollment for patients with SLE, SSc, IIM, and SPS in 1Q25, and for patients with AAV in 2H25. The Company plans to report preliminary clinical data from the Phase 1 clinical study of ADI-001 in LN in 1H25, and for other autoimmune diseases in 2H25, subject to study site initiation and patient enrollment."

Enrollment status • P1 data • ANCA Vasculitis • Immunology • Lupus • Lupus Nephritis • Systemic Lupus Erythematosus • Systemic Sclerosis

Adicet Bio to Present at the American College of Rheumatology (ACR) Convergence 2024 (Businesswire) - "Adicet Bio, Inc...announced acceptance of an oral presentation at the upcoming American College of Rheumatology (ACR) Convergence 2024 meeting, taking place November 14-19, 2024, in Washington, D.C."

Preclinical • Immunology

A Phase 1 Study of ADI-001 in Lupus Nephritis (clinicaltrials.gov) - P1 | N=40 | Recruiting | Sponsor: Adicet Therapeutics | Not yet recruiting ➔ Recruiting | Initiation date: Jun 2024 ➔ Nov 2024

Enrollment open • Trial initiation date • Glomerulonephritis • Immunology • Inflammatory Arthritis • Lupus • Lupus Nephritis • Nephrology

A Phase 1 Study of ADI-001, an Allogeneic CD20-Targeted γδ CAR T cell Therapy, in Adults with Autoimmune Disease (KIDNEY WEEK 2024) - P1 | "Mukhtyar C, et al. Ann Rheum Dis, 2009"

CAR T-Cell Therapy • Clinical • P1 data • ANCA Vasculitis • Glomerulonephritis • Hematological Malignancies • Immunology • Inflammatory Arthritis • Interstitial Lung Disease • Lupus • Lupus Nephritis • Nephrology • Oncology • Pulmonary Disease • Rare Diseases • Renal Disease • Respiratory Diseases • Scleroderma • Systemic Lupus Erythematosus • Systemic Sclerosis • Vasculitis

Adicet Bio Announces FDA Clearance of IND Amendment to Evaluate ADI-001 in Idiopathic Inflammatory Myopathy and Stiff Person Syndrome (Businesswire) - "Adicet Bio, Inc...announced that the U.S. Food and Drug Administration (FDA) has agreed to an amendment to the Company’s Investigational New Drug (IND) application to evaluate ADI-001 in idiopathic inflammatory myopathy (IIM) and stiff person syndrome (SPS) as part of the ongoing Phase 1 trial in autoimmune diseases. The Company plans to initiate enrollment for IIM and SPS patients in the first quarter of 2025. This announcement follows the FDA’s recent agreements on amendments to the Company’s ADI-001 IND application to evaluate three additional indications beyond lupus nephritis (LN), including systemic lupus erythematosus (SLE), systemic sclerosis (SSc) and anti-neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis (AAV)."

IND • New P1 trial • Immunology • Lupus • Lupus Nephritis • Systemic Lupus Erythematosus • Systemic Sclerosis

Adicet Opens Enrollment for ADI-001 Phase 1 Clinical Trial in Autoimmune Diseases (Businesswire) - "Adicet Bio...today announced the opening of enrollment for the Phase 1 clinical trial evaluating ADI-001 in autoimmune diseases....'We expect to have several additional sites open for enrollment by the end of the fourth quarter of 2024, and further increase the number of active sites during the first quarter of 2025. At this time, our sites are open to enroll patients with LN, and we plan to initiate enrollment of patients with SLE, SSc, and AAV in the fourth quarter of this year."

Enrollment status • ANCA Vasculitis • Lupus Nephritis • Systemic Lupus Erythematosus • Systemic Sclerosis

Adicet Reports Second Quarter 2024 Financial Results and Provides Business Updates (Businesswire) - "The Company has initiated startup activities at multiple clinical sites and plans to commence enrollment in its Phase 1 clinical trial of ADI-001 in lupus nephritis in the third quarter of 2024, with preliminary clinical data expected in the first half of 2025, subject to site initiation and patient enrollment....In connection with the Company’s Phase 1 clinical trial of ADI-001 in autoimmune disease, enrollment of SLE, SSc and AAV patients is expected to commence in the second half of 2024. Clinical data from the Company’s Phase 1 clinical trial of ADI-001 in SLE, SSc and AAV patients are anticipated during the first half of 2025, subject to site initiation and patient enrollment expectations."

Enrollment status • New P1 trial • P1 data • Immunology • Lupus • Lupus Nephritis • Systemic Lupus Erythematosus • Systemic Sclerosis

GLEAN-1: A Phase 1 Study of ADI-001 in B Cell Malignancies (clinicaltrials.gov) - P1 | N=78 | Active, not recruiting | Sponsor: Adicet Therapeutics | Recruiting ➔ Active, not recruiting | Trial primary completion date: Dec 2025 ➔ Jul 2025

Enrollment closed • Trial primary completion date • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Hematological Malignancies • Lymphoma • Mantle Cell Lymphoma • Marginal Zone Lymphoma • Mediastinal B Cell Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

Adicet Reports Second Quarter 2024 Financial Results and Provides Business Updates (Businesswire) - "Contingent upon study initiation progress, the Company intends to initiate the Phase 1 clinical trial of ADI-270 in RCC patients in the fourth quarter of 2024 and present preliminary clinical data from the study in the first half of 2025, subject to site initiation and patient enrollment....Enrollment of mantle cell lymphoma (MCL) patients ongoing in ADI-001 Phase 1 GLEAN study. Adicet is continuing to enroll MCL patients in the Phase 1 trial evaluating ADI-001 in relapsed or refractory non-Hodgkin’s Lymphoma. The Company plans to provide a clinical update in the fourth quarter of 2024."

P1 data • P1/2 data • Trial status • Genito-urinary Cancer • Hematological Malignancies • Kidney Cancer • Lymphoma • Mantle Cell Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Renal Cell Carcinoma • Solid Tumor

Adicet Bio Receives FDA Fast Track Designation for ADI-001 in Lupus Nephritis (Businesswire) - "Adicet Bio, Inc...announced the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to ADI-001 for the potential treatment of relapsed/refractory class III or class IV lupus nephritis....'We plan to initiate our Phase 1 clinical study in lupus nephritis later this month'."

Fast track • Trial status • Immunology • Lupus • Lupus Nephritis

Adicet Reports First Quarter 2024 Financial Results and Provides Business Updates (Businesswire) - "The Company plans to commence a Phase 1 clinical trial to assess the safety and efficacy of ADI-001 in lupus nephritis in the second quarter of 2024. Preliminary data from the study are anticipated during the fourth quarter of 2024 or first quarter of 2025, depending on patient enrollment and study site activation."

New P1 trial • P1 data • Immunology • Lupus Nephritis

Adicet Reports First Quarter 2024 Financial Results and Provides Business Updates (Businesswire) - "Hematologic malignancies and solid tumor indications:...Adicet is continuing to enroll MCL patients in the Phase 1 trial evaluating ADI-001 in relapsed or refractory non-Hodgkin’s Lymphoma (NHL). The Company remains on track to provide a clinical update on safety, efficacy and 6-month complete response data in MCL patients in the second half of 2024."

Enrollment status • P1 data • Mantle Cell Lymphoma

GLEAN-1: A Phase 1 Study of ADI-001 in B Cell Malignancies (clinicaltrials.gov) - P1 | N=78 | Recruiting | Sponsor: Adicet Bio, Inc | Trial completion date: Mar 2024 ➔ Dec 2027 | Trial primary completion date: Mar 2023 ➔ Dec 2025

Trial completion date • Trial primary completion date • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Hematological Malignancies • Lymphoma • Mantle Cell Lymphoma • Marginal Zone Lymphoma • Mediastinal B Cell Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

A Phase 1 Study of ADI-001 in Lupus Nephritis (clinicaltrials.gov) - P1 | N=40 | Not yet recruiting | Sponsor: Adicet Bio, Inc

New P1 trial • Glomerulonephritis • Immunology • Inflammatory Arthritis • Lupus • Lupus Nephritis • Nephrology

dicet Reports Fourth Quarter and Full Year 2023 Financial Results and Highlights Recent Company Progress (Businesswire) - "R&D expenses were $24.8 million for the three months ended December 31, 2023, compared to $25.0 million during the same period in 2022. The $0.2 million decrease was primarily driven by a $2.7 million decrease in expenses related to contract development manufacturing organizations (CDMOs), contract research organizations (CROs) and consultant costs related to our lead product candidate ADI-001."

Commercial • Lupus Nephritis • Mantle Cell Lymphoma